SOURCES SOUGHT
A -- Fellowship
- Notice Date
- 8/7/2008
- Notice Type
- Sources Sought
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-08-1046046
- Point of Contact
- Karen R. Petty,, Phone: 301-827-8774
- E-Mail Address
-
karen.petty@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- Solicitation: FDA-08-1046046 Agency/Office: Food and Drug Administration Location: Office of Acquisitions and Grants Services Title: Fellowship Description(s): THIS IS A SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this sources sought. Any responses received will not be used as a proposal. The U.S. Food and Drug Administration (FDA) is seeking to identify any sources with capabilities or prior experience that can provide Professional Services for a Fellowship program in accordance with the following statement of work: STATMENT OF WORK: Background The purpose of the fellowship program is to develop a cohort of trained fellows who will be especially prepared to take up the challenges of drug information and risk communication. This program is being undertaken to introduce participants to the various medical and regulatory aspects of drug development. I.Objectives: •The primary objective of the program is to introduce participants to various medical and regulatory aspects of drug development. •Train health care professionals for a career in the drug development industry by allowing them “hands on” experience. •Understand regulations regarding human drug products. •Understand the value of drug information to heath care providers and to consumers. II.Structure and Content of Program: The Fellowship requires two years of on-site participation administered through an accredited College of Pharmacy. The fellow will be a PharmD. graduate and will have rotational experiences at an academic institution, the Food and Drug Administration, Center for Drug Evaluation and Research, and either pharmaceutical company identified above. The fellow is expected to complete a project that incorporates viewpoints and aspects of the rotational experience. III.Training Tracks Within the Pharmaceuticals Drug Development Fellowship Program Although certain training elements are common to all fellows the three distinct training tracks identified within the program will allow tailoring of training to the career goals of the individual trainee. The training tracks are as follows: 1) Drug Information Track Division of Drug Information •Utilize drug information references to facilitate communication through dissemination of timely and clinically significant information for drug products, and CDER’s role, etc. •Respond to inquiries regarding approved drugs •Become familiar with drug products, regulations, guidance documents and timely issues 2)Prescription Drug Advertising Track Division of Post marketing Advertisement and Communication (DDMAC) •Reviews and evaluates promotional materials for compliance with regulations. These include materials from the Internet and exhibit halls of medical meetings and materials used by pharmaceutical sales representatives. •Reviews and evaluates promotional claims to determine if they are substantiated by the labeling and/or medical journal articles. IV.Candidate Qualifications Candidates must be a PharmD. Graduate from an accredited institution. Highly Qualified candidates will possess the following competencies and skills: •Knowledge of the drug development and review process •Knowledge of the risk management framework •Knowledge of Post-marketing epidemiological assessment •Knowledge of basic health promotion-health education concepts •Knowledge of basic social marketing perspective and strategies •Excellent oral and verbal communication skills •Excellent written communication skills •PowerPoint presentation skills •Interest in computer and web-based communication tools V.Roles and Responsibilities The Center for Drug Evaluation and Research (CDER) will: •Appoint a Coordinator for the Joint Academic/FDA/Industry fellowship Program in Pharmaceutical Drug Development. •Appoint mentor(s) who will guide the fellow during their stay at CDER •Jointly with the participating organizations periodically review and revise the objectives and programmatic assignments of the fellows. •Authorize the Coordinator to serve as a liaison between the Food and Drug Administration, Center for Drug Evaluation and Research and the Academic institution. •Accept one fellow per programmatic area per fellowship cycle. Additional fellows will be accepted at CDER’s sole discretion. •Inform the academic institution when CDER recommends withdrawal of any fellow from the Fellowship Program whose performance is unsatisfactory. The Contractor shall: •Provide a stipend to the person selected for the fellowship. •Maintain completion of records and reports necessary for the conduct and verification of student participation. •Monitor the progress of the fellow and establish criteria for the successful completion of the fellowship. •Designate a faculty member to coordinate with a designee from the specific programmatic area the fellow is assigned. •Coordinate the educational experience. •Serves as central resource for fellow regarding their development. •Coordinates recruitment and candidate selection. VI.At no time during the course of the fellowship will the participant be considered an employee of the Food and Drug Administration, Center for Drug Evaluation and Research. Fellows shall, however, adhere to the rules, regulations, procedures, and policies of the Food and Drug Administration, Center for Drug Evaluation and Research while of the premises and during that portion of the fellowship, including but not limited to completion of a Confidentiality and Nondisclosure Acknowledgement. The Food and Drug Administration, center for Drug Evaluation and Research has the right to terminate the use of its facilities and its resources by any Fellow for violation of its rules, regulations, procedures and policies. VII.This agreement may be amended by mutual consent by the officials executing this agreement or their successor after giving written notice to the other party at least 30 days prior to the proposed amendment date. This agreement shall become effective upon execution by the signatories. Either party may terminate this Agreement upon sixty- (60) days written notice to the other. Subject to mutual agreement of the parties, such termination may not prevent those students already participating in the Fellowship program from completing their assignment at the FDA, Center for Drug Evaluation and Research Companies are encouraged to respond if they have the capability and capacity to provide the identified services with little or no disruption of services to the current users at the FDA. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required. Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform each of the tasks described above at a sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above wile in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 15 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and fax numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 611310 with size limitation standards of $6.5M and status, if qualified as an 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number (TIN), and company structure (Corporation, LLC, partnership, joint venture, etc). Companies also must be registered in the Central Contractor Registration (CCR) at www.ccr.gov to be considered as potential sources. 5. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation, such as letters or certificates to indicate the firm's status (see item #3 above). To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. Interested offerors should submit their capability statement not exceeding fifteen (15) pages in length, excluding standard brochures. SUBMISSIONS ARE DUE no later than 3:00pm, Eastern Time, August 14, 2008. The capabilities response shall be e-mailed to: Karen.petty@fda.hhs.gov. All information received in response to this notice that is marked Proprietary will be handled accordingly. Responses to the notice will not be returned, nor will there be any ensuing discussions or debriefings of any responses. Information provided in response to this notice will be used to assess alternatives available for determining how to proceed in the acquisition process. This notice is part of Government Market Research, a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for or award a competitive contract. The FDA will use the information submitted in response to this notice at its discretion and will not provide comments to any submission; however, the content of any responses to this notice may be reflected in subsequent solicitation. FDA reserves the right to contact any respondent to this notice for the sole purpose of enhancing FDA's understanding of the notice submission. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. It is emphasized that this is a notice for planning and information purposes only and is not be construed as a commitment by the government to enter into a contractual agreement, nor will the government pay for information solicited.
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